Umbilical HerniaNOTESNCT01398215
Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Transvaginal Ventral Hernia Repair
An observational study of Umbilical Hernia and Ventral Hernia, run by University of California, San Diego at 1 site in United States.
Trial summary
This is a prospective chart review/data collection study of natural orifice translumenal endoscopic surgery (NOTES) for ventral hernia repair, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a transvaginal NOTES ventral hernia repair. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Umbilical Hernia, Ventral Hernia
- What is being tested?
- transvaginal NOTES ventral hernia repair
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All patients who come to the UC San Diego Surgical Specialties clinic and have chosen to undergo a ventral hernia repair will be evaluated for participation in this tria
Who may be able to join
- Umbilical or incisional hernia greater than 2 cm in size
- Female, age 18-75
- Mentally competent to give informed consent
- Scheduled to undergo a transvaginal NOTES ventral hernia repair
Who cannot join
- Pregnant women
- Patients with defects measuring greater than 10 cm in size
- Patients with complex hernias requiring fascial mobilization for closure
- Morbidly obese patients (BMI >45)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of California, San Diego Medical Center
San Diego, California, 92103
Sarah Lazar, MPH, 619-471-0447, misresearch@ucsd.edu
Garth Jacobsen, M.D.
About this study
This is a prospective chart review/data collection study of natural orifice translumenal endoscopic surgery (NOTES) for ventral hernia repair, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a transvaginal NOTES ventral hernia repair. Data will be collected and reviewed through 12 months post-op.
- Conditions
- Umbilical Hernia, Ventral Hernia
- Being tested
- transvaginal NOTES ventral hernia repair
- Keywords
- umbilical hernia, ventral hernia
- Medical subject headings
- Hernia, Umbilical, Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transvaginal NOTES ventral hernia repairProcedure or surgery
ventral hernia repair via the transvaginal approach
| Study group | Role | What they receive |
|---|---|---|
| transvaginal NOTES | Not described Receives: Procedure: transvaginal NOTES ventral hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess outcomes related to the transvaginal NOTES approach to laparoscopic ventral hernia repair (through data collection).
Measured: 1 Year
To assess pain associated with the transvaginal NOTES approach to laparoscopic ventral hernia repair (through data collection).
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startJan 2009
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical HerniaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Garth Jacobsen, MD, University of California, San Diego
- Investigators
- Garth Jacobsen, M.D., Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398215
- Sponsor's protocol ID
- 081038, 150520
- Acronym
- NOTES
- Status last verified
- Apr 2018
- First submitted
- 14 Jul 2011
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Transvaginal Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT01398215
- Acronym / sponsor ID
- NOTES / 081038, 150520
- Conditions
- Umbilical Hernia, Ventral Hernia
- Keywords
- umbilical hernia, ventral hernia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective chart review/data collection study of natural orifice translumenal endoscopic surgery (NOTES) for ventral hernia repair, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a transvaginal NOTES ventral hernia repair. Data will be collected and reviewed through 12 months post-op.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transvaginal NOTES | – | Procedure: transvaginal NOTES ventral hernia repair |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who come to the UC San Diego Surgical Specialties clinic and have chosen to undergo a ventral hernia repair will be evaluated for participation in this tria
Key inclusion criteria (4 listed)
- Umbilical or incisional hernia greater than 2 cm in size
- Female, age 18-75
- Mentally competent to give informed consent
- Scheduled to undergo a transvaginal NOTES ventral hernia repair
Key exclusion criteria (4 listed)
- Pregnant women
- Patients with defects measuring greater than 10 cm in size
- Patients with complex hernias requiring fascial mobilization for closure
- Morbidly obese patients (BMI >45)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transvaginal NOTES ventral hernia repairventral hernia repair via the transvaginal approach | Procedure or surgery | transvaginal NOTES |
Primary outcome
To assess outcomes related to the transvaginal NOTES approach to laparoscopic ventral hernia repair (through data collection).
Time frame: 1 Year
To assess pain associated with the transvaginal NOTES approach to laparoscopic ventral hernia repair (through data collection).
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garth Jacobsen, M.D. principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Umbilical Hernia and Ventral Hernia, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Lazar, MPH (619-471-0447, misresearch@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess outcomes related to the transvaginal NOTES approach to laparoscopic ventral hernia repair (through data collection). (time frame: 1 Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.